Fatty acids, C18-24, zinc salts

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity studies in a tyre plant: in vitro activity of workers' urinary concentrates and raw materials

Author:

Crebelli R, Paoletti A, Falcone E, Aquilina G, Fabri G and Carere A

Year:

1985

Bibliographic source:

Br. J. Ind. Med. 42(7):481-487

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

(No data of negetive control)

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Zinc oxide

EC Number:

215-222-5

EC Name:

Zinc oxide

Cas Number:

1314-13-2

Molecular formula:

OZn

IUPAC Name:

oxozinc

Constituent 2

Reference substance name:

215-222-3

IUPAC Name:

215-222-3

Details on test material:

- Name of test material (as cited in study report): Zinc oxide
- Substance type: Pure active substance
- Physical state : No data
- Analytical purity: 99%

Method

Target gene:

No data

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Details on mammalian cell type (if applicable):

No data

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 fraction from Aroclor induced male Sprague-Dawley rats

Test concentrations with justification for top dose:

1000-5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Migrated to IUCLID6: at 5 µg/plate

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene at 1 µg/plate

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylendiamine at 5 µg/plate

Details on test system and experimental conditions:

METHOD OF APPLICATION: In agar (plate incorporation)
NUMBER OF REPLICATIONS: Triplicate

Evaluation criteria:

Positive response: Induction of reproducible dose related increases in the number of his+ revertants in the treated group compared to the control.

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

None

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The test material was considered to be non-mutagenic under the condition of this test.

Executive summary:

A study was conducted to determine the potential mutagenicity of Zinc oxide using bacterial reverse mutation assay.

Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 were treated with the test material using the plate incorporation method at dose levels ranging from 1,000 to 5,000 µg/plate in triplicate in presence and absence of a metabolic activation system.

No significant increases in the frequency of his+ revertant colonies were recorded at the dose range tested.

The test material was considered to be non-mutagenic under the conditions of this test.